WO2022053857A1 - Cerebrospinal fluid (csf) sterilizer equipment by pef & uv technology for patients with csf infection & meningitis - Google Patents

Cerebrospinal fluid (csf) sterilizer equipment by pef & uv technology for patients with csf infection & meningitis Download PDF

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Publication number
WO2022053857A1
WO2022053857A1 PCT/IB2020/058521 IB2020058521W WO2022053857A1 WO 2022053857 A1 WO2022053857 A1 WO 2022053857A1 IB 2020058521 W IB2020058521 W IB 2020058521W WO 2022053857 A1 WO2022053857 A1 WO 2022053857A1
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catheter
cerebrospinal fluid
fluid
liquid
catheters
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PCT/IB2020/058521
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French (fr)
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Majid MOHAMMADIKHOSHBAKHT
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Mohammadikhoshbakht Majid
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002Implant devices for drainage of body fluids from one part of the body to another
    • A61M27/006Cerebrospinal drainage; Accessories therefor, e.g. valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0017Filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029Radiation
    • A61L2/0047Ultraviolet radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/14Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002Implant devices for drainage of body fluids from one part of the body to another
    • A61M2027/004Implant devices for drainage of body fluids from one part of the body to another with at least a part of the circuit outside the body

Definitions

  • a device that sterilize pathogenic microorganisms in the cerebrospinal fluid separates its large particles, and controls the pressure and temperature of the CSF consisting of: catheters, pumps that pump cerebrospinal fluid from inside of the head into the device and flows it in the catheter and device, circulates and returns it to the body, sterilizing elements that kill pathogenic microorganisms inside the CSF, filtering agents that separate CSF particles, the intracranial cerebrospinal fluid pressure regulator which drains excess fluid and controls ICP pressure, and the cooling system which controls cerebrospinal fluid temperature.
  • CSF is transferred from inside the brain and spinal cord to the device by a catheter and a pump circulate it through different parts of the device and its inside particles are separated by a filter, and the pressure of the fluid inside the brain is controlled and the cerebrospinal fluid is sterilized.
  • the fluid temperature is controlled by the cooling system and the fluid is cooled and returned to the brain and spinal cord by a catheter.
  • This medical equipment is designed for patients with cerebrospinal fluid infection or meningitis to sterilizes and filters the cerebrospinal fluid by destroying infectious and pathogenic agents in the CSF without using any drugs
  • Cerebrospinal fluid is a clear, colorless body fluid, found in the brain and spinal cord. It is produced by the specialized ependymal cells in the choroid plexuses of the ventricles of the brain, and absorbed in the arachnoid granulations. There is about 125 to 150 mL of CSF at any one time, and about 500 mL is generated every day.
  • CSF occupies the subarachnoid space (between the arachnoid mater and the pia mater) and the
  • CSF vascular endothelial growth factor
  • Concentrations of bacteria in cerebrospinal fluid ranged from 4.5 X 10 ⁇ 3 to 3 X 10 ⁇ 8 colony-forming units/ml in 27 patients with bacterial meningitis before antibiotic therapy. All patients with persistent positive cultures had pretreatment concentrations of 10 ⁇ 7 CFU/ml or greater
  • Acute bacterial meningitis is rapidly developing inflammation of the layers of tissue that cover the brain and spinal cord (meninges) and of the fluid-filled space between the meninges (subarachnoid space) when it is caused by bacteria
  • Meningitis is an acute inflammation of the protective membranes covering the brain and spinal cord, known collectively as the meninges. The most common symptoms are fever, headache, and neck stiffness. The inflammation may be caused by infection with viruses, bacteria, or other microorganisms, and less commonly by certain drugs. Meningitis can be life-threatening because of the inflammation's proximity to the brain and spinal cord
  • the first treatment in acute meningitis consists of promptly giving antibiotics and sometimes antiviral drug.
  • Corticosteroids can also be used to prevent complications from excessive inflammation. Meningitis can lead to serious long-term consequences such as deafness, epilepsy, hydrocephalus, or cognitive deficits, especially if not treated quickly
  • the large-scale inflammation that occurs in the subarachnoid space during meningitis is not a direct result of bacterial infection but can rather largely be attributed to the response of the immune system to the entry of bacteria into the central nervous system.
  • components of the bacterial cell membrane are identified by the immune cells of the brain, they respond by releasing large amounts of cytokines, hormone-like mediators that recruit other immune cells and stimulate other tissues to participate in an immune response.
  • the blood–brain barrier becomes more permeable, leading to vasogenic cerebral edema (swelling of the brain due to fluid leakage from blood vessels). Large numbers of white blood cells enter the CSF, causing inflammation of the meninges and leading to interstitial edema (swelling due to fluid between the cells).
  • ICP intracranial pressure
  • Some consequences of applying this apparatus could be: reduction of bacterial and viral population in CSF, reduction in quantity of bulky particle in CSF, CSF viscosity reduction, regulation of intracranial pressure, control of CSF temperature, cebral edema and inflammation improvement, white blood cells population reduction.
  • cerebrospinal fluid is sucked into the device from inside the ventricles of the brain or the area between the vertebrae, then its relatively large particles such as white blood cells, fungi and bacteria and other particles are removed by mechanical filter from It is separated and the remaining fluid is exposed to ultraviolet light as well as pulsed electric field and kills microorganisms and infectious agents remaining in the fluid. ICP is also controlled by mechanisms.
  • U.S. Patent No. 8232046 which deals with the distinction between bacterial and viral meningitis.
  • Brain multimodality integrated US Patent Application No. 20100240971 A device for monitoring brain parameters in a patient, comprising at least one function sensor for central nervous system, at least one brain oxygen sensor, at least one blood flow sensor, a video monitor and a computing circuit.
  • the nervous system function sensor is set to detect the patient's nervous system functionality.
  • the brain oxygen sensor is set to regulate the patient's oxygen concentration.
  • the sensor for brain blood flow rate is set to regulate the patient's blood flow rate.
  • Computational circuit communicate with the function sensor of nervous system and the oxygen sensor of the brain.
  • the computational circuit is configured to display a graphical display the patient's nervous system function and the oxygen concentration of the patient's brain through a monitor.
  • the injectable medical device with disinfectant is a US patent number 7596408.
  • the implantable medical device may be set up to be placed in the patient's head to monitor or treat the brain.
  • the implantable medical device may have one chamber, or a chamber with a component to provide a smooth connection between the device and adjacent tissue.
  • the disinfectant may be smeary in the organ or area.
  • the device contains an individual module, while in other embodiments multiple modules are included to provide a smaller profile.
  • the implantable device may contain both disinfectants and lubricants. The difference between the invented designs and my design is that some infectious agents are removed by the device before entering other parts through the mechanical filter.
  • the cerebrospinal fluid disinfection device by PEF & UV technology consists of three main parts.
  • the third part is responsible for cooling the liquid.
  • the task of pumping and circulating the liquid through different parts of the device is the responsibility of a rotary pump, it is a roller that has no contact with the liquid and slides on the catheter by creating a rotational motion and pushes the liquid forward.
  • the pressure sensors are responsible for detecting the CSF pressure
  • the lateral discharge system is responsible for regulating the pressure.
  • composition of cerebrospinal fluid is similar to blood, except that it does not contain red blood cells and platelets, and protein particles and blood cells are found in it.
  • a mechanical filter made of non-woven and compressed polymer fibers is used to trap and capture the particles larger than one micron and separate them from the liquid. The separation procedure occurs based on the property of liquid diffusion and osmosis, and particles are trapped based on their size, and then the filtration takes place.
  • the cerebrospinal fluid meters the sterile part, which its first part is made of the UV light after passing through the filter.
  • a capillary helical catheter network is created around the UV light, in order to make maximum use of UV light, and due to the long path of this catheter around the lamp UV, the radiation absorption time by cerebrospinal fluid is maximized.
  • the UV wavelength used in this device is in the range of 254, which has the most destructive and lethal effect on pathogenic microorganisms. To increase the antibacterial effect at this stage, the liquid should be away from visible light and more exposed to UV light.
  • the cerebrospinal fluid enters the sterile area using Pulsed Electric Field technology after passing around the UV lamp, and is made from two parallel electrodes made of steel or aluminum separated by an insulating plate. In the middle of these electrodes, a duct containing cerebrospinal fluid is placed made of helical catheters consisting of transparent silicon
  • the electrodes have no contact with the cerebrospinal fluid and are only used to create an alternating current around the catheter and the fluid.
  • the high potential difference is provided by the transformation and stored in capacitors moving at a speed of 5 X 10 ⁇ 10 times per second using the oscillator circuit of the positive and negative poles of the field.
  • the electric field ionizes the charged particles inside the pathogenic cells and the charged ions are absorbed towards the opposite pole.
  • the temperature of cerebrospinal fluid increases slightly after passing through a sterile unit with UV and a pulsed electric field.
  • the liquid temperature is reduced by a cooling unit.
  • the cooling unit consists of a double-glazed copper chamber with a set of spiral catheters in the middle. The empty space around the chamber is filled with a liquid consisting of water and ethylene glycol. This liquid is cooled by a powerful fan through a stream of air after passing through a radiator made of parallel metal plates. After cooling in the radiator, the coolant returns to the double-glazed metal chamber and returns to the radiator after heat exchange with the metal plate and the spin cerebral fluid.
  • the coolant flow in this system is assisted by a pump, as the speed of the pump increases and reducing the temperature of coolant in the radiator and cooling of the metal chamber, the temperature of the cerebrospinal fluid decreases.
  • the temperature of coolant and cerebrospinal fluid outlet is adjusted by the physician through the gauge on the instrument panel.
  • the intracranial pressure (ICP) of cerebrospinal fluid (CSF) is always received by a sensor and displayed on a screen. If the pressure is too high, some of the liquid is removed from the system. In this way, the liquid is directed to the discharge system by the solenoid valve when it enters the device and closure of the main path of the catheter.
  • a fluid port is provided for sampling of cerebrospinal fluid.
  • another input port is installed after the sterile system for injecting of medical drugs.
  • This device uses a catheter to evoke cerebrospinal fluid from the brain ventricles of a patient with meningitis into the device and completely eliminates bacteria and viruses inside the cerebrospinal fluid using UV light via pulsed electric field technology, separates white blood cells and large particles as well as the dead bacteria of from the cerebrospinal fluid through filters and return it back to the ventricles of the brain. At the same time, it measures and controls the intracranial pressure (ICP) and its temperature. With this method, the device removes infectious agents and suspended particles from the cerebrospinal fluid and reduces the complications of meningitis, including cerebral inflammation, edema, and high intracranial pressure.
  • ICP intracranial pressure
  • the cerebrospinal fluid is sucked into the device from inside the ventricles of the brain or the area between the vertebrae using special catheters, then its larger particles such as white blood cells, fungi, bacteria, and other particles are removed by a mechanical filter. After that, the remaining liquid is exposed to ultraviolet light as well as pulsed electric field which leads to degradation of microorganisms and infectious agents inside the liquid.
  • the cerebrospinal fluid is cooled after sterilization by a cooling system, which reduces the patient's fever after entering the body. ICP is also controlled by mechanisms.
  • the device consists of three main parts: First: Catheter and rotary pump that receive cerebrospinal fluid from the brain and transfer it into the device and rotate it between different parts of the device, then return it to the body and also control the ICP pressure. Second: The sterile part that separates the two large particle filters in the liquid and then enters the sterile part with UV rays and then sterile with Pulsed Electric Field and the third part which is responsible for cooling the liquid.
  • the task of pumping and moving the liquid in different parts of the device is the responsibility of a rotary and roller pump that has no contact with the liquid and slides on the catheter by creating a rotational motion and pushes the liquid forward.
  • the amount of cerebrospinal fluid pressure is the responsibility of the pressure sensors and the pressure regulation is the responsibility of the lateral discharge system.
  • cerebrospinal fluid has a composition similar to blood, except that it does not contain red blood cells and platelets, and protein particles and blood cells are found in it.
  • a mechanical filter made of non-woven and compressed polymer fibers, in which particles larger than one micron are trapped in the fibers and separated from the liquid. The separation operation occurs due to the property of liquid diffusion and osmosis, and based on the size of the bodies, the material is trapped in it and the filtration operation takes place. Also, some of the infectious agents are removed by this filter before entering the rest of the device. This filter is disposable and needs to be replaced if a patient's treatment lasts longer.
  • cerebrospinal fluid After passing through the filter, cerebrospinal fluid enters the sterile part, the first part of which consists of a UV lamp.
  • a capillary network and a spiral of catheters have been created around the UV lamp to maximize the use of UV light. Due to the long path of this catheter around the UV lamp, the duration of radiation absorption by cerebrospinal fluid is maximized.
  • the UV wavelength used in this device is in the range of 254, which has the most destructive and lethal effect on pathogenic microorganisms. To increase the antibacterial effect at this stage, the liquid should be away from visible light and more exposed to UV light.
  • the cerebrospinal fluid After passing near the UV lamp, the cerebrospinal fluid enters the sterile area using Pulsed Electric Field technology, which consists of two parallel electrodes made of steel or aluminum, which are separated by an insulating plate.
  • Pulsed Electric Field technology which consists of two parallel electrodes made of steel or aluminum, which are separated by an insulating plate.
  • a duct containing cerebrospinal fluid which consists of spiral catheters made of clear transparent silicone.
  • the electrodes have no contact with CSF and only create an oscillating electric field around the catheter and the fluid.
  • the high potential difference is supplied by the transformer and stored in capacitors and the positive and negative poles of the field oscillate at a speed of 5X10 ⁇ 10 times per second.
  • the electric field ionizes the charged particles inside the pathogenic cells and the charged ions are absorbed to the opposite pole. This process is reversed by changing the polarity of the electrodes, leading to rupture of the bacterial cell wall and destruction of the contents inside the cell.
  • the temperature of cerebrospinal fluid increases slightly after passing through a sterile unit with UV and pulsed electric field.
  • the liquid temperature is lowered by the cooling unit.
  • the cooling unit consists of a double-walled copper chamber in the middle of which there is a set of spiral catheters. The empty space around the chamber is filled with a liquid consisting of water and ethylene glycol. This solution is cooled by a powerful fan after passing through a radiator made of parallel metal plates. the coolant returns to the double-walled metal chamber after cooling in the radiator, and returns to the radiator after heat exchange with the metal plate and the CSF.
  • the coolant flow in this system is assisted by a pump, which decreases the temperature of the CSF by increasing the pump speed and as a result, the coolant in the radiator and the metal chamber cool down.
  • the temperature of the cooling chamber and the CSF is adjusted by the physician through a control screw on the device panel.
  • the intracranial pressure (CSF) inside the ventricle is continuously monitored by a sensor and displayed on a screen. If the pressure is too high, some of the fluid will leave the system. In this way, when the fluid enters the device and the main path of the catheter closes, it is directed to the drainage system by a solenoid valve, which is accompanied by the opening of the discharge valve. The fluid is directed from this path into the catheter and then into the discharge bag, and it will be replaced when it’s filled. This process continues until the ICP pressure become normal. The liquid is then directed back to the main route and the sterile system. In the transit catheter, a fluid port is provided for sampling of cerebrospinal fluid. Also, another input port is installed next to the sterile system for injecting medications.
  • CSF intracranial pressure
  • All parts that are in contact with the cerebrospinal fluid are disposable and for each patient a new catheter set including a filter and drainage bag, spiral catheters around the UV lamp, catheters inside the sterile pulsed electric field unit, and inside the cooling system is used.
  • a silicon (FIG. 1) catheter In order to transfer the cerebrospinal fluid from the brain ventricles into the device a silicon (FIG. 1) catheter is used. Silicone is a polymer with a high resistance to temperature and chemicals and does not react chemically with substances in the body, so it is considered as a relatively ideal polymer for medical use.
  • the end of the 72.1 catheter is closed and there are small holes 73 to allow the fluid to enter. To prevent large particles in the cerebrospinal fluid from entering into the tube and to prevent clogging, we increase the number of holes with small size.
  • the holes 73 are located at the proximal end. To see the flow of cerebrospinal fluid inside the tube, it is better to use clear polymer to make a catheter.
  • Catheters may include one or two ducts
  • a one-way catheter When we elicit the cerebrospinal fluid from the brain ventricles and enter the lumbar region after sterilization a one-way catheter is used but if we take the fluid from the ventricle and return it to the same ventricle after sterilization we use the two-way catheter
  • the end of the catheter is intended for input of the fluid to the catheter and above that a hole 87 is considered for fluid to return to the ventricle.
  • the location of inlet and outlet ducts is so important
  • the catheter inserted into the lumbar spine region is thinner and more flexible than the catheter placed inside the head, and it is necessary to take this point into account when making the catheter.
  • To insert the catheter first the skull is pierced with a drill and then the ventricular catheter is entered into the brain ventricles in the lateral ventricle by a metal introducer.
  • the silicon ventricular catheter which has 85 holes in the proximal region, sucks the cerebrospinal fluid from the lateral ventricle and sends it into the device. It should be remembered that the cerebrospinal fluid inside the catheter is full of pathogenic microorganisms such as bacteria, viruses, and etc. that have caused infection in the patient's brain and meningitis.
  • the catheter As pathogenic microorganisms can enter the brain from outside the body through the catheter holes on the skull, the catheter is coated with Nano silver compounds or antibiotics such as Rifampicin and Clindamycin during production process.
  • the production of these drug-coated catheters is by first preparing a container containing chloroform as a solvent and dissolve a very small amount of the antibiotic rifampicin or Nano-silver in it, then the circular shape catheters are immersed in the solution for 24 hours.
  • This catheter can be used for packaging and sterilization.
  • the drug in the catheter is gradually released which takes more than twenty days to completely release the medication. This method prevents the drug from being released all at once in the first few hours and is released gradually and evenly over several days. So, the antimicrobial effect will remain for days.
  • the ventricular catheter After implantation on the skull, the ventricular catheter is connected to the input catheter by a metal connector. All the catheters used in this device must be sterilized with ethylene oxide gas or a sterile plasma device before use, after the production process, and before the packaging.
  • two (FIG.5) pumps are used.
  • a peristaltic pump in which the liquid flows inside the catheter without any contact with the pump components.
  • a peristaltic pump (FIG. 5 AND FIG. 6) is a type of positive displacement pump used for pumping a variety of fluids, they are also commonly known as roller pumps.
  • the fluid is contained within a flexible tube 6,7 fitted inside a circular pump casing 1&5 (though linear peristaltic pumps have been made).
  • a rotor 2 with a number of rollers andshoes3.1attached to the external circumference of the rotor compresses the flexible tube 6& 7. As the rotor 2 turns, the part of the tube under compression is pinched closed and occluded thus forcing the fluid to be pumped to move through the tube. Additionally, as the tube opens to its natural state after the passing of the cam (restitution or "resilience) fluid flow is induced to the pump.
  • rollers or wipers 3&4, occluding the tube, trapping between them a body of fluid.
  • the body of fluid is then transported, at ambient pressure, toward the pump outlet.
  • Peristaltic pumps may run continuously, or they may be indexed through partial revolutions to deliver smaller amounts of fluid.
  • a cross-shaped holder is used.
  • Figures 9, 10 and 11 The intensity of the pump output and the speed of liquid movement are controlled by the adjustable screw on the control panel of the device. This screw increases or decreases the speed of the electric motor.
  • ICP intracranial pressure
  • a fluid drainage system including a flexible three-way cross-shaped catheter, two solenoid valves, a one-way filter 66 which air does not pass through but liquid passes (to prevent air bubbles from entering the catheters), and a disposable 65 polymer drainage bag with a volume of 300 cc is used.
  • the ICP pressure is constantly monitored by a sensor 81 inside the ventricular catheter (Fig 3).
  • a sensor 81 inside the ventricular catheter Fig 3
  • the cerebrospinal fluid enters through the 67.2 duct and the activation of solenoid valve 70 and compression of the 67.3 catheter to 68 plate, the path to the drainage bag is closed and at the same time the solenoid valve 69 is inactive and the main path of device 67 is open, and the fluid exits the duct 67.1 and will be transferred to the UV portion of (Fig 10).
  • the lateral drainage system (Fig. 7) will be activated.
  • the solenoid valve 69, piece 71 presses on the catheter 67 and blocks the main path.
  • the solenoid valve 70 is deactivated and the path 67.3 is opened and the liquid enters the bag 65 after passing through the filter 66 and accumulates there. The bag is replaced and destroyed after filling.
  • cerebrospinal fluid in two stages of FIG mechanical filter.
  • the CSF is passed through compressed non-woven polymer fibers twice (Fig.8.16).
  • This filter which is cylindrical and made of non-woven and compressed polymer fibers of polypropylene or polyester, separate and trap particles larger than one micron.
  • This filter (FIG. 8) is disposable and can be replaced at the end of the process.
  • the cerebrospinal fluid enters the filter from the middle duct of one side 13, and since the end of this duct is 19 closed and it is full of small holes 20, the fluid exits through these small holes 20 and enters the fibrous tissue 16.
  • the liquid is passed through this compact microfiber tissue 16. Particles larger than one micron are captured and the remaining filtered fluid enters the large outer lumen through the small holes 14 on the lateral duct 17, then it is collected by the pipe 17 and exits through the outlet 15 and 18 and transfers to the next stage.
  • the cerebrospinal fluid passes through the device and the filter several times, the filtration process completes and the cerebrospinal fluid gets clearer.
  • cerebrospinal fluid is entered into a sterile system by the (FIG.10) ultraviolet light and the long spiral path of interlocking catheters (FIG.11) around the lamp and the mirror cylinder 43 around it.
  • the sterile UV a cylindrical UV lamp with a wavelength of 254 nm, which has the most destructive effect on the bacterial cell is used. factors that have the greater impact on UV rays include the wavelength, duration, and the intensity of the radiation.
  • the produced radiation is absorbed by the bacterial cell wall and degrades proteins and DNA inside the cell, it disrupts vital cellular activities and leads to the bacterial death.
  • the UV 41 lamp is located in the center of the 40-catheter spiral network and required power is supplied by the power supply through the 37, 38 and 35 wires.
  • the UV ray is produced by igniting the filaments 44, inside the 41 cylindrical glass.
  • the whole set of lamps 41 and the inside catheter 40 are placed in a metal cylinder 43 and 42, the surface of which is glossy and mirrored so that UV light is reflected and trapped in the cylinder and does not come out, and to maximize the UV light efficiency (Fig.10).
  • the 40 catheters used in this section and around the lamp should be made of a material that has the lowest UV absorption rate.
  • the CSF enters the sterile UV set through the 39th tube, then passes through the spiral path 40 and receives UV radiation, and exits the system through the output channel 34 and goes to the next part.
  • the cerebrospinal fluid After leaving the sterile section, the cerebrospinal fluid enters the sterile section by pulsed electric field.
  • a pulsed electric field induces a strong electric field to the particles in the liquid that cause ionization, also rapid changes in the field polarity have destructive effect on the cell wall and inner components of bacteria and viruses.
  • we use two parallel steel plates 25 and 25.1 and to separate and insulate the two poles of the electrodes 25 and 25.1 we use a layer of fireproof insulation paper 29 that sticks to one of the electrode plates. The insulation and safety are very important due to the high voltage of the electrodes.
  • a large number of needle pins 29 are installed as a heatsink and coolant on the outer surface of the metal electrodes 25 and 25.1, which expel some heat as air passes through them.
  • the cerebrospinal fluid is enters from one side of the pulse field electrode system 225 and 25.1, by the catheter through the 27th conduit, and exits through the duct 26 from other sides of the catheters and above the electric field, after being affected by the alternative electric field. It is noteworthy to mention that the liquid has no contact with the surface of the electrodes. the 25.2 helical catheter is removed from its place between the electrodes and discarded and replaced by new catheters after each use.
  • the electric force of the electrodes is generated by a 20,000-volt 21 transformer and then stored in capacitors, and poles oscillate up to -5X10 ⁇ 10 times per second by an electrical field.
  • the transformer consists of a coil wrapped around a metal core 22 and a metal protective shield.
  • the high voltage power is connected to the positive electrode by connection number 31 and wire 23 and the connection to electrode 33.
  • the negative pole of this electrode is connected to the negative electrode by the connection point No. 30 and the high voltage wire 24 and the connection point 32.
  • the electric poles applied from the trans to the electrodes oscillates alternately 5X10 ⁇ 10 times per second by the electrical circuit.
  • disposable electrodes can be used instead of permanent electrodes.
  • a bag made of flexible medical polymer, with a spiral tube form inside from top to bottom is used, with both sides covered with flexible thin aluminum layers similar to those used in packaging of juice. Then these two aluminum layers are connected to the power supply circuit by a connector, and when the cerebrospinal fluid flows through it, a current is established and a pulsed electric field is created, and finally discarded after use.
  • FIG 14, FIG 15 we use a cooling system (FIG 14, FIG 15).
  • a cooling system for this purpose, we use a 45 metal box made of copper, which contains 3 separate chambers- i.e. two chambers on both sides containing water and alcohol coolant, 2-53 and 3-53, and one in the middle, including a cooler chamber.
  • a disposable spiral catheter 64 is placed which contains cerebrospinal fluid, and the CSF enters the spiral catheter through the inlet duct 63 and exits through the duct 62 after cooling.
  • the cooling chamber 2-53 and 3-53 consist of ninety-four percent water, four percent ethylene glycol and 2 of nanoparticles, which absorb the heat emitted from the cerebrospinal fluid, heats the copper chamber in turn, and exits the chamber and transfer it to the radiator 60.
  • the fluid containing water and ethylene glycol with this volume percentage has a thermal conductivity of 0.540 W / MK, which is suitable for medical applications because it is not toxic and does not pose a risk to the patient's health.
  • Alcohol-water solution plays the role of heat conductor and absorbs the heat generated in chamber 4-53 by the cerebrospinal fluid, transmits it through duct 48 and 47 and tubes 52 and 51 to radiator 60.
  • Cerebrospinal fluid pathogen sterilizer that separates large particles from cerebrospinal fluid and controls the pressure and temperature of cerebrospinal fluid
  • ICP pressure regulator Includes the intracranial cerebrospinal fluid pressure regulator, which drains excess fluid and controls ICP pressure.
  • Cerebrospinal fluid large particle separator filter composed of non-wowen polymer polymer compact fibers
  • Sterile section of cerebrospinal fluid by ultraviolet light including UV lamp and a network of catheters carrying fluid around it and a mirror cylinder around them
  • UV unit output port 35 UV lamp wire 36: UV lamp wire 37: UV lamp wire 38: UV lamp wire 39: UV unit input port 40: Spiral pipeline containing CSF 41: UV lamp 42: UV unit housing 43: External surface of UV housing 44: Internal mirror surface of UV housing
  • UV unit input port 40 Spiral pipeline containing CSF 34: UV unit output port
  • UV unit output port 35 UV lamp wire 36: UV lamp wire 37: UV lamp wire 38: UV lamp wire 39: UV unit input port 40: Spiral pipeline containing CSF 41: UV lamp 42: UV unit housing 43: External surface of UV housing 44: Internal mirror surface of UV housing
  • Transformation cover 22 Transformation core coverage 23: AC input cable 24: AC input cable 25: Heat sink barbs 25.1: Heat sink plate 25.2: Pipeline containing CSF 26: PEF unit output port 27: PEF unit input port 29: Insulator Layer 30: Transformation electric output connection 31: Transformation electric output connection 32: PEF electrode connection 33: PEF electrode connection
  • This device extracts the cerebrospinal fluid from the brain ventricles of a patient with meningitis using a catheter and completely destroys bacteria and viruses in CSF using UV light and pulsed electric field technology. Large white blood cells and bacterial dead bodies are separated from the cerebrospinal fluid through filters and return the CSF goes back to the brain ventricles. At the same time, the ICP and its temperature is measured and controlled. With this method, the device removes infectious agents and suspended particles from the CSF and reduces the complications of meningitis, including cerebral inflammation, edema, and high intracranial pressure.
  • This device can be used in medical centers and hospitals to sterilize pathogenic microorganisms of cerebrospinal fluid and to control the pressure and temperature of cerebrospinal fluid.

Abstract

A device that sterilize pathogenic microorganisms in the cerebrospinal fluid, separates its large particles, and controls the pressure and temperature of the CSF consisting of: catheters, pumps that pump cerebrospinal fluid from inside of the head into the device and flows it in the catheter and device, circulates and returns it to the body, sterilizing elements that kill pathogenic microorganisms inside the CSF, filtering agents that separate CSF particles, the intracranial cerebrospinal fluid pressure regulator which drains excess fluid and controls ICP pressure, and the cooling system which controls cerebrospinal fluid temperature. CSF is transferred from inside the brain and spinal cord to the device by a catheter and a pump circulate it through different parts of the device and its inside particles are separated by a filter, and the pressure of the fluid inside the brain is controlled and the cerebrospinal fluid is sterilized.

Description

Cerebrospinal fluid (CSF) Sterilizer Equipment by PEF & UV Technology for Patients with CSF Infection & Meningitis
A device that sterilize pathogenic microorganisms in the cerebrospinal fluid, separates its large particles, and controls the pressure and temperature of the CSF consisting of: catheters, pumps that pump cerebrospinal fluid from inside of the head into the device and flows it in the catheter and device, circulates and returns it to the body, sterilizing elements that kill pathogenic microorganisms inside the CSF, filtering agents that separate CSF particles, the intracranial cerebrospinal fluid pressure regulator which drains excess fluid and controls ICP pressure, and the cooling system which controls cerebrospinal fluid temperature.
CSF is transferred from inside the brain and spinal cord to the device by a catheter and a pump circulate it through different parts of the device and its inside particles are separated by a filter, and the pressure of the fluid inside the brain is controlled and the cerebrospinal fluid is sterilized. The fluid temperature is controlled by the cooling system and the fluid is cooled and returned to the brain and spinal cord by a catheter.
Physics (G) – information and communication technology (G16) – healthcare informatics (G15H)
This medical equipment is designed for patients with cerebrospinal fluid infection or meningitis to sterilizes and filters the cerebrospinal fluid by destroying infectious and pathogenic agents in the CSF without using any drugs
Cerebrospinal fluid (CSF) is a clear, colorless body fluid, found in the brain and spinal cord. It is produced by the specialized ependymal cells in the choroid plexuses of the ventricles of the brain, and absorbed in the arachnoid granulations. There is about 125 to 150 mL of CSF at any one time, and about 500 mL is generated every day.
CSF occupies the subarachnoid space (between the arachnoid mater and the pia mater) and the
Ventricular system around and inside the brain and spinal cord. It fills the ventricles of the brain, cisterns, and sulci, as well as the central canal of the spinal cord. CSF is derived from blood plasma and is largely similar to it, except that CSF is nearly protein-free compared with plasma and has some different electrolyte levels. CSF contains approximately 0.3% plasma proteins, or approximately 15 to 40 mg/dL, depending on sampling site. This continuous flow into the venous system dilutes the concentration of larger, lipid-insoluble molecules penetrating the brain and CSF. CSF is normally free of red blood cells, and at most contains only a few white blood cells
Concentrations of bacteria in cerebrospinal fluid ranged from 4.5 X 10^3 to 3 X 10^8 colony-forming units/ml in 27 patients with bacterial meningitis before antibiotic therapy. All patients with persistent positive cultures had pretreatment concentrations of 10^7 CFU/ml or greater
Acute bacterial meningitis is rapidly developing inflammation of the layers of tissue that cover the brain and spinal cord (meninges) and of the fluid-filled space between the meninges (subarachnoid space) when it is caused by bacteria
When microorganisms such as bacteria attack the meninges and subarachnoid space, the immune system reacts to the invaders, and immune cells gather to defend the body against them. The outcome is inflammation and meningitis which can cause many complications
Meningitis is an acute inflammation of the protective membranes covering the brain and spinal cord, known collectively as the meninges. The most common symptoms are fever, headache, and neck stiffness. The inflammation may be caused by infection with viruses, bacteria, or other microorganisms, and less commonly by certain drugs. Meningitis can be life-threatening because of the inflammation's proximity to the brain and spinal cord
Giving antibiotics to people with significant exposure to certain types of meningitis may also be useful. The first treatment in acute meningitis consists of promptly giving antibiotics and sometimes antiviral drug. Corticosteroids can also be used to prevent complications from excessive inflammation. Meningitis can lead to serious long-term consequences such as deafness, epilepsy, hydrocephalus, or cognitive deficits, especially if not treated quickly
In 2015, meningitis occurred in about 8.7 million people worldwide. This resulted in 379,000 deaths – down from 464,000 deaths in 1990
Bacteria that enter the bloodstream and travel to the brain and spinal cord cause acute bacterial meningitis. But it can also occur when bacteria directly invade the meninges. This may be caused by an ear or sinus infection, a skull fracture, or, rarely, after some surgeries
The large-scale inflammation that occurs in the subarachnoid space during meningitis is not a direct result of bacterial infection but can rather largely be attributed to the response of the immune system to the entry of bacteria into the central nervous system. When components of the bacterial cell membrane are identified by the immune cells of the brain, they respond by releasing large amounts of cytokines, hormone-like mediators that recruit other immune cells and stimulate other tissues to participate in an immune response. The blood–brain barrier becomes more permeable, leading to vasogenic cerebral edema (swelling of the brain due to fluid leakage from blood vessels). Large numbers of white blood cells enter the CSF, causing inflammation of the meninges and leading to interstitial edema (swelling due to fluid between the cells). In addition, the walls of the blood vessels themselves become inflamed (cerebral vasculitis), which leads to decreased blood flow and a third type of edema, cytotoxic edema. The three forms of cerebral edema all lead to increased intracranial pressure
It is recognized that administration of antibiotics may initially worsen the process outlined above, by increasing the amount of bacterial cell membrane products released through the destruction of bateriabacteria. One complication of meningitis is the development of increased intracranial pressure (ICP)
Without medical intervention, the cycle of decreasing CSF, worsening cerebral edema, and increasing ICP proceeds unchecked. Ongoing endothelial injury may result in vasospasm and thrombosis, further compromising CSF, and may lead to stenosis of large and small vessels. Systemic hypotension also may impair CSF, and the patient soon dies as a consequence of systemic complications or diffuse CNS ischemic injury.
The increased CSF viscosity resulting from the influx of plasma components into the subarachnoid space and diminished venous outflow lead to interstitial edema. The accumulation of the products of bacterial degradation, neutrophils, and other cellular activation leads to cytotoxic edema. The ensuing cerebral edema (vasogenic, cytotoxic, and interstitial) significantly contributes to intracranial hypertension and a consequent decrease in cerebral blood flow. Eventually, if this uncontrolled process is not modulated by effective treatment, transient neuronal dysfunction or permanent neuronal injury results
To prevent dangerous consequences of meningitis, wide spectrum and potent antibiotics should be administrated with high doses but these medicines have extremely adverse side effects and sometimes does not result in favorable and instant outcomes
In order to reduce the adverse effects of infected cerebrospinal fluid in a patient with meningitis, such as a significant increase in the population of bacteria and white blood cells as well as coarse protein particles and intracranial pressure, we recommend using a cerebrospinal fluid sterilizer as described in this patent. This device improves the symptoms of this dangerous disease by cerebrospinal fluid filtering and removing waste particles
Some consequences of applying this apparatus could be: reduction of bacterial and viral population in CSF, reduction in quantity of bulky particle in CSF, CSF viscosity reduction, regulation of intracranial pressure, control of CSF temperature, cebral edema and inflammation improvement, white blood cells population reduction.
In this invention, using special catheters, cerebrospinal fluid is sucked into the device from inside the ventricles of the brain or the area between the vertebrae, then its relatively large particles such as white blood cells, fungi and bacteria and other particles are removed by mechanical filter from It is separated and the remaining fluid is exposed to ultraviolet light as well as pulsed electric field and kills microorganisms and infectious agents remaining in the fluid. ICP is also controlled by mechanisms. Here we review domestic and international patents: U.S. Patent No. 8232046, which deals with the distinction between bacterial and viral meningitis. This is an in vitro method for detecting bacterial meningitis involves determining the concentration of procalcitonin in a blood sample and proteins in a cerebrospinal fluid and comparing the concentrations. Procalcitonin and other proteins in a reference sample, also relates to a kit for the detection of procalcitonin and proteins in cerebrospinal fluid and their use to produce a diagnostic tool for bacterial meningitis. Brain multimodality integrated US Patent Application No. 20100240971: A device for monitoring brain parameters in a patient, comprising at least one function sensor for central nervous system, at least one brain oxygen sensor, at least one blood flow sensor, a video monitor and a computing circuit. The nervous system function sensor is set to detect the patient's nervous system functionality. The brain oxygen sensor is set to regulate the patient's oxygen concentration. The sensor for brain blood flow rate is set to regulate the patient's blood flow rate. Computational circuit communicate with the function sensor of nervous system and the oxygen sensor of the brain. The computational circuit is configured to display a graphical display the patient's nervous system function and the oxygen concentration of the patient's brain through a monitor. The injectable medical device with disinfectant is a US patent number 7596408. The implantable medical device may be set up to be placed in the patient's head to monitor or treat the brain. The implantable medical device may have one chamber, or a chamber with a component to provide a smooth connection between the device and adjacent tissue. The disinfectant may be smeary in the organ or area. In some embodiments, the device contains an individual module, while in other embodiments multiple modules are included to provide a smaller profile. In other embodiments, the implantable device may contain both disinfectants and lubricants. The difference between the invented designs and my design is that some infectious agents are removed by the device before entering other parts through the mechanical filter.
The cerebrospinal fluid disinfection device by PEF & UV technology consists of three main parts. First: a catheter and a rotary pump that receive cerebrospinal fluid from the brain and transfer it into the device and circulate it through different parts of the device, then return it back to the body and also controls the ICP pressure. Second: the sterile part that has two filters and separates large particles in the liquid, then enters the sterile section with UV rays and then sterilized with Pulsed Electric Field. The third part is responsible for cooling the liquid. The task of pumping and circulating the liquid through different parts of the device is the responsibility of a rotary pump, it is a roller that has no contact with the liquid and slides on the catheter by creating a rotational motion and pushes the liquid forward. By changing the motor speed of this pump, the liquid movement in the device, the amount of fluid leaving the device, and the amount of its entry into the device can be adjusted. the pressure sensors are responsible for detecting the CSF pressure, and the lateral discharge system is responsible for regulating the pressure.
One of the causes of inflammation, edema and acute implications in the brain is an increase in the number of white blood cells as well as the bacteria and other particles in the ventricles and cavities surrounding the brain, which need to be removed as much as possible. As we know, composition of cerebrospinal fluid is similar to blood, except that it does not contain red blood cells and platelets, and protein particles and blood cells are found in it. For this purpose, a mechanical filter made of non-woven and compressed polymer fibers is used to trap and capture the particles larger than one micron and separate them from the liquid. The separation procedure occurs based on the property of liquid diffusion and osmosis, and particles are trapped based on their size, and then the filtration takes place.
Also, some of the infectious agents are removed by this filter before entering the device. This filter is disposable and in case of prolonged treatment, it is necessary for a patient to replace it. The cerebrospinal fluid meters the sterile part, which its first part is made of the UV light after passing through the filter. A capillary helical catheter network is created around the UV light, in order to make maximum use of UV light, and due to the long path of this catheter around the lamp UV, the radiation absorption time by cerebrospinal fluid is maximized. The UV wavelength used in this device is in the range of 254, which has the most destructive and lethal effect on pathogenic microorganisms. To increase the antibacterial effect at this stage, the liquid should be away from visible light and more exposed to UV light. The cerebrospinal fluid enters the sterile area using Pulsed Electric Field technology after passing around the UV lamp, and is made from two parallel electrodes made of steel or aluminum separated by an insulating plate. In the middle of these electrodes, a duct containing cerebrospinal fluid is placed made of helical catheters consisting of transparent silicon
The electrodes have no contact with the cerebrospinal fluid and are only used to create an alternating current around the catheter and the fluid. The high potential difference is provided by the transformation and stored in capacitors moving at a speed of 5 X 10 ^ 10 times per second using the oscillator circuit of the positive and negative poles of the field. The electric field ionizes the charged particles inside the pathogenic cells and the charged ions are absorbed towards the opposite pole. By changing the polarity of the electrodes, this process is reversed, which leads to the breakage of the bacterial cell wall and the destruction of the contents inside the cell, and eventually the complete destruction of the cell.
The temperature of cerebrospinal fluid increases slightly after passing through a sterile unit with UV and a pulsed electric field. In order to prevent a rise in the patient's body temperature and to help reducing the fever in a patient with meningitis, the liquid temperature is reduced by a cooling unit. The cooling unit consists of a double-glazed copper chamber with a set of spiral catheters in the middle. The empty space around the chamber is filled with a liquid consisting of water and ethylene glycol. This liquid is cooled by a powerful fan through a stream of air after passing through a radiator made of parallel metal plates. After cooling in the radiator, the coolant returns to the double-glazed metal chamber and returns to the radiator after heat exchange with the metal plate and the spin cerebral fluid. The coolant flow in this system is assisted by a pump, as the speed of the pump increases and reducing the temperature of coolant in the radiator and cooling of the metal chamber, the temperature of the cerebrospinal fluid decreases. The temperature of coolant and cerebrospinal fluid outlet is adjusted by the physician through the gauge on the instrument panel. The intracranial pressure (ICP) of cerebrospinal fluid (CSF) is always received by a sensor and displayed on a screen. If the pressure is too high, some of the liquid is removed from the system. In this way, the liquid is directed to the discharge system by the solenoid valve when it enters the device and closure of the main path of the catheter.
The fluid enters this path into the catheter and then into the evacuation bag, and the bag is replaced when it is filled. This continues until the ICP pressure returns to normal. The fluid is then directed back to the main path and the sterile system. In the passing catheter, a fluid port is provided for sampling of cerebrospinal fluid. Also, another input port is installed after the sterile system for injecting of medical drugs. Before connecting the device to the catheter and collecting the cerebrospinal fluid, we add some normal saline to the catheters of the device to fill all the catheters and parts of the device and to compensate for the dead volume. Then we connect the catheters to the device so that the cerebrospinal fluid enters the device. All the parts connected with the cerebrospinal fluid are disposable, and a new catheter set including filter and discharge bag and spiral catheters around the UV lamp and inside the sterile unit of pulsed electric field as well as inside the cooling system is used for each patient. This device uses a catheter to evoke cerebrospinal fluid from the brain ventricles of a patient with meningitis into the device and completely eliminates bacteria and viruses inside the cerebrospinal fluid using UV light via pulsed electric field technology, separates white blood cells and large particles as well as the dead bacteria of from the cerebrospinal fluid through filters and return it back to the ventricles of the brain. At the same time, it measures and controls the intracranial pressure (ICP) and its temperature. With this method, the device removes infectious agents and suspended particles from the cerebrospinal fluid and reduces the complications of meningitis, including cerebral inflammation, edema, and high intracranial pressure.
Solution of problem
In this invention the cerebrospinal fluid is sucked into the device from inside the ventricles of the brain or the area between the vertebrae using special catheters, then its larger particles such as white blood cells, fungi, bacteria, and other particles are removed by a mechanical filter. After that, the remaining liquid is exposed to ultraviolet light as well as pulsed electric field which leads to degradation of microorganisms and infectious agents inside the liquid. In addition, the cerebrospinal fluid is cooled after sterilization by a cooling system, which reduces the patient's fever after entering the body. ICP is also controlled by mechanisms.
The device consists of three main parts: First: Catheter and rotary pump that receive cerebrospinal fluid from the brain and transfer it into the device and rotate it between different parts of the device, then return it to the body and also control the ICP pressure. Second: The sterile part that separates the two large particle filters in the liquid and then enters the sterile part with UV rays and then sterile with Pulsed Electric Field and the third part which is responsible for cooling the liquid.
The task of pumping and moving the liquid in different parts of the device is the responsibility of a rotary and roller pump that has no contact with the liquid and slides on the catheter by creating a rotational motion and pushes the liquid forward. By changing the motor speed of this pump, you can adjust the speed of liquid movement in the device and the amount of fluid leaving the device and the amount of it entering the device, and also control the pressure of cerebrospinal fluid at the entrance and exit of fluid to the catheter and device. The amount of cerebrospinal fluid pressure is the responsibility of the pressure sensors and the pressure regulation is the responsibility of the lateral discharge system.
One of the causes of inflammation, edema and acute problems in the brain is an increase in the number of white blood cells, as well as the body of bacteria and other particles in the ventricles and cavities around the brain, which need to be separated as much as possible. As we know, cerebrospinal fluid has a composition similar to blood, except that it does not contain red blood cells and platelets, and protein particles and blood cells are found in it. For this purpose, a mechanical filter made of non-woven and compressed polymer fibers, in which particles larger than one micron are trapped in the fibers and separated from the liquid. The separation operation occurs due to the property of liquid diffusion and osmosis, and based on the size of the bodies, the material is trapped in it and the filtration operation takes place. Also, some of the infectious agents are removed by this filter before entering the rest of the device. This filter is disposable and needs to be replaced if a patient's treatment lasts longer.
After passing through the filter, cerebrospinal fluid enters the sterile part, the first part of which consists of a UV lamp. A capillary network and a spiral of catheters have been created around the UV lamp to maximize the use of UV light. Due to the long path of this catheter around the UV lamp, the duration of radiation absorption by cerebrospinal fluid is maximized. The UV wavelength used in this device is in the range of 254, which has the most destructive and lethal effect on pathogenic microorganisms. To increase the antibacterial effect at this stage, the liquid should be away from visible light and more exposed to UV light.
After passing near the UV lamp, the cerebrospinal fluid enters the sterile area using Pulsed Electric Field technology, which consists of two parallel electrodes made of steel or aluminum, which are separated by an insulating plate.
In the middle of these electrodes there is a duct containing cerebrospinal fluid, which consists of spiral catheters made of clear transparent silicone. The electrodes have no contact with CSF and only create an oscillating electric field around the catheter and the fluid. The high potential difference is supplied by the transformer and stored in capacitors and the positive and negative poles of the field oscillate at a speed of 5X10^10 times per second. The electric field ionizes the charged particles inside the pathogenic cells and the charged ions are absorbed to the opposite pole. This process is reversed by changing the polarity of the electrodes, leading to rupture of the bacterial cell wall and destruction of the contents inside the cell.
The temperature of cerebrospinal fluid increases slightly after passing through a sterile unit with UV and pulsed electric field. In order to prevent rising the patient's body temperature and to help reducing the patient’s fever suffering from meningitis, the liquid temperature is lowered by the cooling unit. The cooling unit consists of a double-walled copper chamber in the middle of which there is a set of spiral catheters. The empty space around the chamber is filled with a liquid consisting of water and ethylene glycol. This solution is cooled by a powerful fan after passing through a radiator made of parallel metal plates. the coolant returns to the double-walled metal chamber after cooling in the radiator, and returns to the radiator after heat exchange with the metal plate and the CSF. The coolant flow in this system is assisted by a pump, which decreases the temperature of the CSF by increasing the pump speed and as a result, the coolant in the radiator and the metal chamber cool down. The temperature of the cooling chamber and the CSF is adjusted by the physician through a control screw on the device panel.
The intracranial pressure (CSF) inside the ventricle is continuously monitored by a sensor and displayed on a screen. If the pressure is too high, some of the fluid will leave the system. In this way, when the fluid enters the device and the main path of the catheter closes, it is directed to the drainage system by a solenoid valve, which is accompanied by the opening of the discharge valve. The fluid is directed from this path into the catheter and then into the discharge bag, and it will be replaced when it’s filled. This process continues until the ICP pressure become normal. The liquid is then directed back to the main route and the sterile system. In the transit catheter, a fluid port is provided for sampling of cerebrospinal fluid. Also, another input port is installed next to the sterile system for injecting medications. Before connecting the device to the catheter and receiving cerebrospinal fluid to compensate for the dead volume inside the catheters, and air depletion in them, we add normal saline into the catheters to fill all the catheters and parts of the device and then connect the catheter to the device for entering the CSF to the device.
All parts that are in contact with the cerebrospinal fluid are disposable and for each patient a new catheter set including a filter and drainage bag, spiral catheters around the UV lamp, catheters inside the sterile pulsed electric field unit, and inside the cooling system is used.
a complete plan is presented with the following details. In order to transfer the cerebrospinal fluid from the brain ventricles into the device a silicon (FIG. 1) catheter is used. Silicone is a polymer with a high resistance to temperature and chemicals and does not react chemically with substances in the body, so it is considered as a relatively ideal polymer for medical use. The end of the 72.1 catheter is closed and there are small holes 73 to allow the fluid to enter. To prevent large particles in the cerebrospinal fluid from entering into the tube and to prevent clogging, we increase the number of holes with small size. The holes 73 are located at the proximal end. To see the flow of cerebrospinal fluid inside the tube, it is better to use clear polymer to make a catheter.
Catheters may include one or two ducts When we elicit the cerebrospinal fluid from the brain ventricles and enter the lumbar region after sterilization a one-way catheter is used but if we take the fluid from the ventricle and return it to the same ventricle after sterilization we use the two-way catheter The end of ​​the catheter is intended for input of the fluid to the catheter and above that a hole 87 is considered for fluid to return to the ventricle. In order to prevent the output fluid from re-entering the catheter the location of inlet and outlet ducts is so important Also in order to make it easier for the catheter to enter the brain during the implantation we make it tapered shape 86 to prevent the liquid inlet port 87 from getting stuck in the skull and other tissues.
The catheter inserted into the lumbar spine region is thinner and more flexible than the catheter placed inside the head, and it is necessary to take this point into account when making the catheter. To insert the catheter, first the skull is pierced with a drill and then the ventricular catheter is entered into the brain ventricles in the lateral ventricle by a metal introducer. The silicon ventricular catheter, which has 85 holes in the proximal region, sucks the cerebrospinal fluid from the lateral ventricle and sends it into the device. It should be remembered that the cerebrospinal fluid inside the catheter is full of pathogenic microorganisms such as bacteria, viruses, and etc. that have caused infection in the patient's brain and meningitis. Therefore, we should work carefully and we should try to prevent the pathogens from entering the brain and also their transfer from the patient to the medical staff. In this regard, all the catheters and parts that are in contact with the infected fluid should be made of silicone and disposable, and used only once for each patient and a new catheter set should be used for the next patient.
In order to measure the fluid pressure inside the brain, which is a vital parameter for the patient's health, we use a pressure receptor micro sensor 81 inside the tube and its bases inside the catheter polymer wall near the end of the tube. We use a temperature sensor 82 inside the catheter to measure the patient's body temperature. In order to transfer information from the sensors, it is necessary to use 83 wires. these wires are better to pass through the catheter wall through the polymer to make more space inside the catheter as much as possible. After connecting the catheter to the device, these wires are connected to the device by the connector and transmit the data from sensors to the device.
As pathogenic microorganisms can enter the brain from outside the body through the catheter holes on the skull, the catheter is coated with Nano silver compounds or antibiotics such as Rifampicin and Clindamycin during production process. The production of these drug-coated catheters is by first preparing a container containing chloroform as a solvent and dissolve a very small amount of the antibiotic rifampicin or Nano-silver in it, then the circular shape catheters are immersed in the solution for 24 hours.
Then remove the catheters and put them in a place to dry completely. This catheter can be used for packaging and sterilization. In addition to the fact that the inner and outer surface of the catheter is completely covered with the drug, some will penetrate into the silicone of the catheter wall. Therefore, after implanting the catheter in the patient's head, the drug in the catheter is gradually released which takes more than twenty days to completely release the medication. This method prevents the drug from being released all at once in the first few hours and is released gradually and evenly over several days. So, the antimicrobial effect will remain for days.
During the catheter implantation by the surgeon, it is necessary to know the amount of catheter that enters the head. For this purpose, we engrave markers with a certain distance on the catheter to easily observe and measure the amount of catheter inserted into the head with the naked eye. It will be more convenient to put a strong and long metal wire as a stylet or introducer in the catheter package, the surgeon can put the stylet inside the catheter before inserting the catheter, then inserts it into the brain so that the catheter easily penetrates into the brain tissue and reach the ventricles. To keep the catheter in place and avoiding any movement or slippage, we use the fixative screws that are screwed into the skull hole and hold the catheter firmly in place.
After implantation on the skull, the ventricular catheter is connected to the input catheter by a metal connector. All the catheters used in this device must be sterilized with ethylene oxide gas or a sterile plasma device before use, after the production process, and before the packaging.
To elicit the cerebrospinal fluid from inside the brain ventricles and to transfer it to the device and circulation of fluid, two (FIG.5) pumps are used. Depending on the condition of the device and the risk of infection, the best option is to use a peristaltic pump in which the liquid flows inside the catheter without any contact with the pump components.
A peristaltic pump (FIG. 5 AND FIG. 6) is a type of positive displacement pump used for pumping a variety of fluids, they are also commonly known as roller pumps. The fluid is contained within a flexible tube 6,7 fitted inside a circular pump casing 1&5 (though linear peristaltic pumps have been made). A rotor 2 with a number of rollers andshoes3.1attached to the external circumference of the rotor compresses the flexible tube 6& 7. As the rotor 2 turns, the part of the tube under compression is pinched closed and occluded thus forcing the fluid to be pumped to move through the tube. Additionally, as the tube opens to its natural state after the passing of the cam (restitution or "resilience) fluid flow is induced to the pump. Typically, there will be two or more rollers, or wipers 3&4, occluding the tube, trapping between them a body of fluid. The body of fluid is then transported, at ambient pressure, toward the pump outlet. Peristaltic pumps may run continuously, or they may be indexed through partial revolutions to deliver smaller amounts of fluid.
To prevent the catheter movements around the rotor 2 and inside the frame of the pump, a cross-shaped holder is used. Figures 9, 10 and 11. The intensity of the pump output and the speed of liquid movement are controlled by the adjustable screw on the control panel of the device. This screw increases or decreases the speed of the electric motor.
One of the most important implications for patients with meningitis is the high intracranial pressure (ICP). To control the ICP, a fluid drainage system (FIG. 7) including a flexible three-way cross-shaped catheter, two solenoid valves, a one-way filter 66 which air does not pass through but liquid passes (to prevent air bubbles from entering the catheters), and a disposable 65 polymer drainage bag with a volume of 300 cc is used.
the ICP pressure is constantly monitored by a sensor 81 inside the ventricular catheter (Fig 3). In a normal situation, the cerebrospinal fluid enters through the 67.2 duct and the activation of solenoid valve 70 and compression of the 67.3 catheter to 68 plate, the path to the drainage bag is closed and at the same time the solenoid valve 69 is inactive and the main path of device 67 is open, and the fluid exits the duct 67.1 and will be transferred to the UV portion of (Fig 10). If the pressure is higher than normal, the lateral drainage system (Fig. 7) will be activated. The solenoid valve 69, piece 71, presses on the catheter 67 and blocks the main path. At the same time, the solenoid valve 70 is deactivated and the path 67.3 is opened and the liquid enters the bag 65 after passing through the filter 66 and accumulates there. The bag is replaced and destroyed after filling.
In meningitis and brain inflammation, the number of white blood cells and other particles increases dramatically in addition to the entry of bacteria or viruses into the cerebrospinal fluid. These changes, which are the natural reaction of the body's defense system against infectious agents, will cause negative consequences in the brain, so in this device we try to separate them from the cerebrospinal fluid by mechanical filters. For this purpose, cerebrospinal fluid in two stages of FIG mechanical filter. In this regard, the CSF is passed through compressed non-woven polymer fibers twice (Fig.8.16). This filter, which is cylindrical and made of non-woven and compressed polymer fibers of polypropylene or polyester, separate and trap particles larger than one micron. This filter (FIG. 8) is disposable and can be replaced at the end of the process.
The cerebrospinal fluid enters the filter from the middle duct of one side 13, and since the end of this duct is 19 closed and it is full of small holes 20, the fluid exits through these small holes 20 and enters the fibrous tissue 16. The liquid is passed through this compact microfiber tissue 16. Particles larger than one micron are captured and the remaining filtered fluid enters the large outer lumen through the small holes 14 on the lateral duct 17, then it is collected by the pipe 17 and exits through the outlet 15 and 18 and transfers to the next stage. As the cerebrospinal fluid passes through the device and the filter several times, the filtration process completes and the cerebrospinal fluid gets clearer.
In the first stage of sterilization, cerebrospinal fluid is entered into a sterile system by the (FIG.10) ultraviolet light and the long spiral path of interlocking catheters (FIG.11) around the lamp and the mirror cylinder 43 around it. In the first stage, the sterile UV, a cylindrical UV lamp with a wavelength of 254 nm, which has the most destructive effect on the bacterial cell is used. factors that have the greater impact on UV rays include the wavelength, duration, and the intensity of the radiation. To maximize the contact time of the liquid inside the catheter 40 with the UV radiation, we create a spiral network of catheter 40 around the 41 lamp. this help to increase the UV radiation received by the cerebrospinal fluid. The produced radiation is absorbed by the bacterial cell wall and degrades proteins and DNA inside the cell, it disrupts vital cellular activities and leads to the bacterial death.
To produce 40 catheters around the UV lamp, we use a transparent, dry medical polymer to keep the 40 catheter in shape. The UV 41 lamp is located in the center of the 40-catheter spiral network and required power is supplied by the power supply through the 37, 38 and 35 wires. The UV ray is produced by igniting the filaments 44, inside the 41 cylindrical glass.
The whole set of lamps 41 and the inside catheter 40 are placed in a metal cylinder 43 and 42, the surface of which is glossy and mirrored so that UV light is reflected and trapped in the cylinder and does not come out, and to maximize the UV light efficiency (Fig.10). the 40 catheters used in this section and around the lamp should be made of a material that has the lowest UV absorption rate. The CSF enters the sterile UV set through the 39th tube, then passes through the spiral path 40 and receives UV radiation, and exits the system through the output channel 34 and goes to the next part.
After leaving the sterile section, the cerebrospinal fluid enters the sterile section by pulsed electric field. (FIG 13). In this section, a pulsed electric field induces a strong electric field to the particles in the liquid that cause ionization, also rapid changes in the field polarity have destructive effect on the cell wall and inner components of bacteria and viruses. For this purpose, we use two parallel steel plates 25 and 25.1 and to separate and insulate the two poles of the electrodes 25 and 25.1 we use a layer of fireproof insulation paper 29 that sticks to one of the electrode plates. The insulation and safety are very important due to the high voltage of the electrodes. In addition, to prevent the high voltage metal electrodes from overheating, a large number of needle pins 29 are installed as a heatsink and coolant on the outer surface of the metal electrodes 25 and 25.1, which expel some heat as air passes through them.
To help the cerebrospinal fluid pass through the electrodes, we use a 25.2 disposable circular dry catheter, located in the middle of this electrode box and enters and exits it from above as a cartridge. The cerebrospinal fluid (CSF) is enters from one side of the pulse field electrode system 225 and 25.1, by the catheter through the 27th conduit, and exits through the duct 26 from other sides of the catheters and above the electric field, after being affected by the alternative electric field. It is noteworthy to mention that the liquid has no contact with the surface of the electrodes. the 25.2 helical catheter is removed from its place between the electrodes and discarded and replaced by new catheters after each use.
The electric force of the electrodes is generated by a 20,000-volt 21 transformer and then stored in capacitors, and poles oscillate up to -5X10 ^ 10 times per second by an electrical field. The transformer consists of a coil wrapped around a metal core 22 and a metal protective shield. The high voltage power is connected to the positive electrode by connection number 31 and wire 23 and the connection to electrode 33. Also, the negative pole of this electrode is connected to the negative electrode by the connection point No. 30 and the high voltage wire 24 and the connection point 32. the electric poles applied from the trans to the electrodes oscillates alternately 5X10^10 times per second by the electrical circuit.
In the pulsed electric field section, disposable electrodes can be used instead of permanent electrodes. A bag made of flexible medical polymer, with a spiral tube form inside from top to bottom is used, with both sides covered with flexible thin aluminum layers similar to those used in packaging of juice. Then these two aluminum layers are connected to the power supply circuit by a connector, and when the cerebrospinal fluid flows through it, a current is established and a pulsed electric field is created, and finally discarded after use.
Patients with meningitis and infections of the nervous system often have fever, so the cerebrospinal fluid entering the device has a high temperature. Also, the temperature of the cerebrospinal fluid rises slightly due to the UV radiation and the electric field. So, to reduce the temperature of the liquid before leaving the device, we use a cooling system (FIG 14, FIG 15). For this purpose, we use a 45 metal box made of copper, which contains 3 separate chambers- i.e. two chambers on both sides containing water and alcohol coolant, 2-53 and 3-53, and one in the middle, including a cooler chamber. In the middle of this chamber, a disposable spiral catheter 64 is placed which contains cerebrospinal fluid, and the CSF enters the spiral catheter through the inlet duct 63 and exits through the duct 62 after cooling.
The cooling chamber 2-53 and 3-53 consist of ninety-four percent water, four percent ethylene glycol and 2 of nanoparticles, which absorb the heat emitted from the cerebrospinal fluid, heats the copper chamber in turn, and exits the chamber and transfer it to the radiator 60. The fluid containing water and ethylene glycol with this volume percentage has a thermal conductivity of 0.540 W / MK, which is suitable for medical applications because it is not toxic and does not pose a risk to the patient's health. Alcohol-water solution plays the role of heat conductor and absorbs the heat generated in chamber 4-53 by the cerebrospinal fluid, transmits it through duct 48 and 47 and tubes 52 and 51 to radiator 60. During the passage through copper tubes 61 into the radiator consisting of thin flat parallel aluminum blades 60, the heat energy inside the copper tube 61 containing water and alcohol is transferred from the copper tube to the flat aluminum plates 60 and then to the ambient air. Each copper tube is glued to two large, 60 flat aluminum plates. The size of the aluminum plate greatly increases the level of air contact with these plates, and therefore the heat inside the copper tube is emitted very quickly after transfer to the 60 aluminum plates. The water-alcohol liquid, returns to chamber 4-53 after cooling through duct 50. To increase the efficiency of the cooling system and the coefficient of thermal conductivity of the coolant, we add a small amount of Nano silver or Nano-copper powder to the liquid. The whole set of radiators, including copper pipes 61 and aluminum blades 60, are firmly placed on a tray 59, which is screwed on the main body of the device.
There is a powerful fan behind this set 56 which is rotated by an electric motor 55 and sends air by pressure between the 60 aluminum plates and cools them. Part 54 protects the fan blades. As a result, the coolant in the copper tube 61 is cooled and it is sent to the outer layer of the double-walled chamber 53.2. the chamber cools by contacting the wall of the chamber, and result in the cooling of CSF and chamber. In addition, the outer wall of the chamber containing CSF, exchanges heat with the ambient air due to the thin parallel vanes 53 and emit its heat in this way. for rapid circulation of water-alcohol coolant in the system and between the chambers containing CSF, an electric motor pump 58 located at the junction of the two series of coils of copper pipes 61 inside the radiator is used.
It discharges some of its heat in this way for the rapid circulation of water-alcohol coolant in the system and between the chamber containing the brain fluid and the radiator from a pump with an electric motor 58 which is located at the junction of two series of copper pipes 61 inside the radiator. The intensity of cooling of this system is adjusted via the control screw provided on the panel of the device by the surgeon, by turning the air conditioner fan 56 on and off automatically. A temperature sensor also detects the CSF temperature before leaving the device and display it on the screen. After this step, the liquid enters a filter (FIG 8) again and then leaves the device and enters the patient's body.
Advantage effects of invention
Cerebrospinal fluid pathogen sterilizer that separates large particles from cerebrospinal fluid and controls the pressure and temperature of cerebrospinal fluid
Contains sterilizing elements that kill pathogenic microorganisms in cerebrospinal fluid
Contains filtering agents that separate particles into the cerebrospinal fluid.
Includes the intracranial cerebrospinal fluid pressure regulator, which drains excess fluid and controls ICP pressure.
Includes a cooling system that controls the temperature of the cerebrospinal fluid.
:
Longitudinal section of a cerebral pathway with a pressure sensor and a temperature sensor and signal transmission wire to the device
:
Transverse incision of a cerebral pathway with a pressure sensor and a temperature sensor and cerebrospinal fluid passage
:
Longitudinal incision of the cerebral catheter with a pressure sensor and a temperature sensor and signal transmission wire to the device
:
Transverse incision of the catheter into two cerebral pathways, one way to receive cerebrospinal fluid and one to return fluid to the brain, with a pressure sensor and a temperature sensor
:
Rotary pump to receive cerebrospinal fluid and move in catheters and its circulation in the device
:
Explosive shape of a rotary pump to receive cerebrospinal fluid and circulate it in the device
:
Spinal cord fluid drainage and cerebrospinal fluid pressure control
:
Cerebrospinal fluid large particle separator filter composed of non-wowen polymer polymer compact fibers
:
Transverse section of large particle filter separating cerebrospinal fluid composed of non-wowen compressed polymer fibers
:
Sterile section of cerebrospinal fluid by ultraviolet light including UV lamp and a network of catheters carrying fluid around it and a mirror cylinder around them
:
Spiral network of catheters carrying cerebrospinal fluid around the UV lamp
:
Longitudinal cut of UV lamp and surrounding catheters plus mirror cylinder around it
:
Explosive form of sterile section by electric field including Pulsed Electric Field and high voltage transformer electrodes and electrodes and vectors and electrical connections
:
Cerebrospinal fluid cooling system with water and alcohol cooling fluid, radiator and air conditioning fan
:
Explosive shape of cerebrospinal fluid cooling system by cooling water and alcohol and its various parts
: 72: External surface of catheter 72.1: Catheter tip 73: Catheter hole 81: Pressure sensor 82: Temperature sensor 83: Sensor connecting wire 84: Catheter hole (output) 85: Catheter hole (input) 86: Wall between two ways of catheter 87: Inside of output catheter 88: Inside of input catheter
: 81: Pressure sensor 82: Temperature sensor
: 72: External surface of catheter 72.1: Catheter tip 73: Catheter hole 81: Pressure sensor 82: Temperature sensor 83: Sensor connecting wire 84: Catheter hole (output) 85: Catheter hole (input) 86: Wall between two ways of catheter 87: Inside of output catheter 88: Inside of input catheter
: 72: External surface of catheter 72.1: Catheter tip 73: Catheter hole 81: Pressure sensor 82: Temperature sensor 83: Sensor connecting wire 84: Catheter hole (output) 85: Catheter hole (input) 86: Wall between two ways of catheter 87: Inside of output catheter 88: Inside of input catheter
: 1: External coverage of rotary pump 2: Rotor 3: Pump roller 3.1: Roller shaft 4: Rotor 5: External coverage of rotary pump downside 6: Input pipe of rotary pump 7: Output pipe of rotary pump 8: Flexible pipe holder 9: Flexible pipe holder 10: Flexible pipe holder 11: Flexible pipe holder.
: 1: External coverage of rotary pump 2: Rotor 3: Pump roller 3.1: Roller shaft 4: Rotor 5: External coverage of rotary pump downside 6: Input pipe of rotary pump 7: Output pipe of rotary pump 8: Flexible pipe holder 9: Flexible pipe holder 10: Flexible pipe holder 11: Flexible pipe holder.
: 65: CSF Collection bag 66: Air filter 67: Main Output pipeline 67.1: Output pipeline port 67.2: Output pipeline port 67.3: Sidelong pipeline 68: Electrical valve 69: Electrical valve 70: Obstructive roller 71: Obstructive roller
: 12: External housing of filter 13: Input port of filter 14: Filter cover hole 15: Output port of filter 16: Filter layers 17: Internal housing of filter 18: Input pipeline bending 19: Internal Punctured surface of filter 20: Holes of input pipe
: 12: External housing of filter 13: Input port of filter 14: Filter cover hole 15: Output port of filter 16: Filter layers 17: Internal housing of filter 18: Input pipeline bending 19: Internal Punctured surface of filter 20: Holes of input pipe
: 34: UV unit output port 35: UV lamp wire 36: UV lamp wire 37: UV lamp wire 38: UV lamp wire 39: UV unit input port 40: Spiral pipeline containing CSF 41: UV lamp 42: UV unit housing 43: External surface of UV housing 44: Internal mirror surface of UV housing
: 39: UV unit input port 40: Spiral pipeline containing CSF 34: UV unit output port
: 34: UV unit output port 35: UV lamp wire 36: UV lamp wire 37: UV lamp wire 38: UV lamp wire 39: UV unit input port 40: Spiral pipeline containing CSF 41: UV lamp 42: UV unit housing 43: External surface of UV housing 44: Internal mirror surface of UV housing
: 21: Transformation cover 22: Transformation core coverage 23: AC input cable 24: AC input cable 25: Heat sink barbs 25.1: Heat sink plate 25.2: Pipeline containing CSF 26: PEF unit output port 27: PEF unit input port 29: Insulator Layer 30: Transformation electric output connection 31: Transformation electric output connection 32: PEF electrode connection 33: PEF electrode connection
: 45: Heat sink plate 46: CSF pipeline casing 47: Coolant fluid output port from heat sink 48: Coolant fluid output port from heat sink 49: Coolant fluid input port into heat sink 50: Coolant fluid input port into heat sink 51: Coolant fluid carrier pipeline into the cooling system 52: Coolant fluid carrier pipeline bending 53: Heat sink wings 53.2: Coolant fluid reservoir 53.4: CSF pipeline casing place 54: Fan shield 55: Electromotor of fan of cooling system 56: Cooling system fan 57: Power supply pedestal 58: Power supply 59: Cooling system holding plate 60: Radiator wings of cooling system 61: Pipeline containing coolant fluid 62: CSF output port 63: CSF output port 64: CSF fluid spiral pipeline in cooling case
: 45: Heat sink plate 46: CSF pipeline casing 47: Coolant fluid output port from heat sink 48: Coolant fluid output port from heat sink 49: Coolant fluid input port into heat sink 50: Coolant fluid input port into heat sink 51: Coolant fluid carrier pipeline into the cooling system 52: Coolant fluid carrier pipeline bending 53: Heat sink wings 53.2: Coolant fluid reservoir 53.4: CSF pipeline casing place 54: Fan shield 55: Electromotor of fan of cooling system 56: Cooling system fan 57: Power supply pedestal 58: Power supply 59: Cooling system holding plate 60: Radiator wings of cooling system 61: Pipeline containing coolant fluid 62: CSF output port 63: CSF output port 64: CSF fluid spiral pipeline in cooling case
Examples
This device extracts the cerebrospinal fluid from the brain ventricles of a patient with meningitis using a catheter and completely destroys bacteria and viruses in CSF using UV light and pulsed electric field technology. Large white blood cells and bacterial dead bodies are separated from the cerebrospinal fluid through filters and return the CSF goes back to the brain ventricles. At the same time, the ICP and its temperature is measured and controlled. With this method, the device removes infectious agents and suspended particles from the CSF and reduces the complications of meningitis, including cerebral inflammation, edema, and high intracranial pressure.
Nowadays, medical control and healthcare is undergoing significant changes by a wide range of facilities and services, due to the more interest and focus on preventing the risks assessment in healthcare and significant advancements in this field. This device can be used in medical centers and hospitals to sterilize pathogenic microorganisms of cerebrospinal fluid and to control the pressure and temperature of cerebrospinal fluid.

Claims (34)

  1. What is claimed to be a sterilizing device for pathogenic microorganisms in the cerebrospinal fluid that uses special catheters to suck the cerebrospinal fluid from the ventricles of the brain or the area between the spine into the device and then its relatively large particles such as white blood cells Fungi, bacteria and other particles are separated by a mechanical filter and the remaining liquid is exposed to ultraviolet light as well as pulsed electric field and kills microorganisms and infectious agents remaining in the liquid. In addition, the cerebrospinal fluid is cooled after sterilization by a cooling system, which reduces the patient's fever after entering the body and ICP is also controlled by mechanisms.
  2. According to claim 1, this device consists of three main parts, first: a catheter and a rotary pump that receive cerebrospinal fluid from the brain and transfer it into the device and rotate it between different parts of the device and then open it into the body. return and also controls the pressure ICP. Second: The sterile part, which separates the two large particle filters in the liquid and enters the sterile part with UV rays and sterile with Pulsed Electric Field, and the third part, which is responsible for cooling the liquid.
  3. According to claim 2, the catheter is made of transparent silicone and its end is closed. For liquid ingress into the holes it created to prevent large particles into the cerebrospinal fluid and prevent the clogging of pipes number of holes’ increases, and their size small is intended and holes through the distal and proximal.
  4. According to claim 3, the catheter designed in this design can be one way or two ways. If cerebrospinal fluid from the ventricles of the brain receive and then sterile lumbar we enter the catheter One way we use, but if the liquid from within the reception and after the filters back into the ventricle back into the catheter two-way use.
  5. According to claim 4, for the convenience of allowing the catheter into the brain during catheter insertion, it forms a flexible and made inclined to avoid consuming a liquid inlet port to the skull and other tissues.
  6. According to claim 5, catheters that are implanted into the lumbar region of the spine is slightly thinner and more flexible catheters that are placed inside the head.
  7. According to claim 6, in order to measure the fluid pressure inside the brain, a pressure receptor micro sensor is used which is inside the tube and its bases are inside the polymer wall of the catheter and close to the end of the tube and temperature sensor is used inside the catheter.
  8. According to claim 7, in order to send information from the sensors into the device, it is necessary to use a wire that these wires are connected to the device after connecting the catheter to the device and transmit the received information of the sensors to the device.
  9. According to claim 8, to prevent pathogenic microorganisms from entering the brain from outside the body, Nano silver compounds or antibiotics such as rifampicin and clindamycin are used to make catheters. Also, all catheters in this device must be sterilized with ethylene oxide gas or sterile plasma device before use and after the production process and before packaging.
  10. According to claim 9, after implanting a catheter in the patient's head, the drug contained in the catheter is released partially and the drug release process takes more than twenty days. This method causes the drug to be taken at once and within hours. the first to be released and to be released in a few days to review and evenly therefore germicidal effect it will remain for days.
  11. According to claim 10, the ventricular catheter, after implantation on the skull, is connected to the input catheter of the device by a metal connector. All catheters used in this device must be used before, after the production process and before packaging and sterilize with ethylene oxide gas or plasma sterilizer.
  12. According to claim 11, for the suction of cerebrospinal fluid from the ventricles of the brain and its transfer to the device and fluid circulation between different parts, two pumps have been used, which according to the condition of the device and the risk of infection, the best option to use It is a peristaltic pump in which the liquid moves inside the catheter without any contact with the pump components.
  13. According to claim 12, the task of pumping and moving the liquid in different parts of the device is the responsibility of the rotary and roller pump, which has no contact with the liquid and slips on the catheter and pushes the liquid forward.
  14. According to claim 13, the speed of fluid movement in the device and the amount of fluid leaving the device and the rate of its entry into the device, cerebrospinal fluid pressure at the site of fluid entry and exit to the catheter and device can be controlled by changes in pump motor speed.
  15. According to claim 14, a cross-shaped retainer is used to prevent the catheter from coming out of its place around the rotor and inside the frame of the pump, and the intensity of the pump output and the speed of liquid movement by the adjusting screw on the control panel of the control device. Becomes. This screw increases or decreases the speed of the electric motor
  16. According to claim 15, for controlling cerebrospinal fluid pressure from a fluid drainage system comprising a flexible three-way catheter, two solenoid valves, and a one-way filter through which air does not pass but fluid does. To prevent air bubbles from entering the catheters) and a disposable polymeric discharge bag with a volume of 300 cc has been used.
  17. According to claim 16, the method of operation of this section is such that the amount of cerebrospinal fluid pressure is always received by the pressure receptor sensor inside the ventricular catheter and is monitored by the device. If the pressure is higher than normal, the lateral drainage system is activated. The solenoid valve presses on the catheter and blocks the main path. At the same time, the solenoid valve is deactivated and the path is opened and the liquid enters the bag after passing through the filter and collects there and is replaced after filling.
  18. According to claim 17, a mechanical filter is used to separate the white blood cells from the cerebrospinal fluid, which is passed in two stages through a mechanical filter with a layer of non-woven compressed polymer fibers.
  19. According to claim 18, this filter is cylindrical and made of non-woven and compressed polymer fibers of propylene or polyester, which separates and traps particles larger than one micron. This filter is disposable and is replaced after the process. The separation action occurs due to the property of liquid diffusion and osmosis, and based on the size and size of the bodies, the material is trapped in it and the filtration action takes place.
  20. According to claim 19, cerebrospinal fluid enters the sterile section after passing through the filter, which is a set of sterile system by ultraviolet radiation plus a long spiral path of intertwined catheters around the lamp and the surrounding mirror cylinder.
  21. According to claim 20, for the first stage of sterile UV, we use a cylindrical UV lamp with a wavelength range of 254 nm, which has the most destructive effect on the bacterial cell.
  22. According to Claim 21, the factors influencing the greater impact of UV radiation are the wavelength, duration of radiation and intensity of the radiation, which is created to maximize the contact time of the liquid inside the catheter with UV radiation. This spiral path around the UV lamp multiplies the UV radiation received by the cerebrospinal fluid.
  23. According to claim 22, the produced beam is absorbed by the cell wall of bacteria and by colliding with proteins and DNA inside the cell, it disrupts vital cellular activities and causes the death of bacteria.
  24. According to claim 23, a transparent dry medical polymer is used to make the catheter around the lamp to keep the catheter in shape. The UV lamp is located in the center of the spiral network of the catheter and receives the electricity it needs from the power supply and is produced by igniting the filament filaments inside the cylindrical UV lamp.
  25. According to claim 24, the entire set of lamps and catheters is placed inside a metal cylinder, the surface of which is polished and mirrored so that the UV light is reflected and trapped in the cylinder and does not come out of it, and the sterile efficiency in the UV section Reach the maximum.
  26. According to claim 25, the cerebrospinal fluid enters the sterile area after passing near the UV lamp using Pulsed Electric Field technology, which is made of two parallel electrodes made of steel or aluminum, which are separated by an insulating plate. In the middle of these electrodes is a duct containing cerebrospinal fluid, which is made of spiral catheters, cartridges, and a cartridge that enters and exits from above, which is made of dry transparent silicone.
  27. According to claim 26, the electric field ionizes the charged particles inside the pathogenic cells and the charged ions are absorbed to the opposite pole. This process is reversed by changing the polarity of the electrodes, leading to rupture of the bacterial cell wall and destruction of the contents and eventually complete cell destruction.
  28. According to claim 27, the electrical force of the electrodes is generated by a twenty-thousand-volt transformer and then stored in capacitors and displaced by an electric circuit instead of poles up to 5X10^10 times per second.
  29. According to claim 28, instead of using a permanent electrode for the pulse electric field section, disposable electrodes can be used in such a way that a bag made of flexible medical polymer is made in the form of a spiral tube from top to bottom. It has been used and we cover both sides with flexible thin aluminum sheets. The two aluminum plates are then connected to the power supply circuit by a connector, and when the cerebrospinal fluid flows through it, a current is established and a pulsed electric field is created, which is discarded after use by a patient.
  30. According to claim 29, the temperature of the cerebrospinal fluid increases slightly after passing through the sterilization units and the temperature of the fluid is lowered by the cooling unit. The cooling unit consists of a double-walled copper metal chamber with a set of spiral catheters in the middle. In fact, there are two compartments on either side of the water and alcohol coolant and one in the middle containing the catheter cooler.
  31. According to claim 30, the empty space around the cooling unit chamber is filled with a liquid consisting of ninety-four percent water, four percent ethylene glycol and 2 percent by volume nanoparticles. This liquid is cooled by a powerful fan after passing through a radiator made of parallel metal plates by a powerful fan.
  32. According to claim 31, the coolant returns to the double-walled metal chamber after cooling in the radiator and returns to the radiator after heat exchange with the metal plate and the brain fluid.
  33. According to claim 32, the coolant flow in this system is done by a pump and an electric motor, which increases the temperature of the coolant by increasing the speed of the pump and as a result, the coolant in the radiator cools down and the metal chamber cools down. The temperature of the cooling chamber and the cerebrospinal fluid outlet is adjusted by the doctor with a control screw on the panel of the device.
  34. According to claim 33, a port fluid for sampling of cerebrospinal fluid is provided in the catheter passing through the catheter, and another input port after the sterile system is also installed for drug injection.
PCT/IB2020/058521 2020-09-14 2020-09-14 Cerebrospinal fluid (csf) sterilizer equipment by pef & uv technology for patients with csf infection & meningitis WO2022053857A1 (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150094644A1 (en) * 2013-10-01 2015-04-02 Md Start Sa Systems and methods for moving and circulating fluid to treat alzheimer's disease
WO2017096228A1 (en) * 2015-12-04 2017-06-08 Minnetronix, Inc. Systems and methods for the conditioning of cerebrospinal fluid

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150094644A1 (en) * 2013-10-01 2015-04-02 Md Start Sa Systems and methods for moving and circulating fluid to treat alzheimer's disease
WO2017096228A1 (en) * 2015-12-04 2017-06-08 Minnetronix, Inc. Systems and methods for the conditioning of cerebrospinal fluid

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